E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00623441
First received: February 18, 2008
Last updated: January 27, 2012
Last verified: September 2009
  Purpose

The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.

This prospective multi-center study has been initiated:

  • To document the acute and mid-term safety and overall clinical performance of the stent system in a "real world" patient population requiring stent implantation.
  • To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.

Condition Intervention
Coronary Artery Disease
Device: Endeavor Zotarolimus Eluting Coronary Stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • MACE (Major Adverse Cardiac Events) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))


Enrollment: 8314
Study Start Date: September 2005
Study Completion Date: February 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endeavor Zotarolimus Eluting Coronary Stent
    Drug eluting stent
    Other Name: Endeavor Stent
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Real-world patients requiring drug eluting stent implantation

Criteria

Inclusion Criteria:

  • Patient is >18 years of age (or minimum age as required by local regulation)
  • The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
  • The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions.
  • Lesion length and vessel diameter of the target lesion(s) are according to the "Indications for Use" as mentioned in the "Instructions for Use" that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System.
  • The patient is willing and able to cooperate with registry procedures and required follow up visits.

Exclusion Criteria:

  • Women with known pregnancy or who are lactating.
  • Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
  • Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
  • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  • Current medical condition with a life expectancy of less than 12 months.
  • The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once.
  • Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623441

Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Ian T Meredith, MD Monash Medical Centre, Melbourne, Australia
Principal Investigator: Chaim Lotan, MD Hadassah University Hospital, Jerusalem, Israel
Principal Investigator: Martin T Rothman, MD London Chest Hospital, London, United Kingdom
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00623441     History of Changes
Obsolete Identifiers: NCT00265668
Other Study ID Numbers: Protocol Final version1.1
Study First Received: February 18, 2008
Results First Received: September 1, 2009
Last Updated: January 27, 2012
Health Authority: Not required: N/A

Keywords provided by Medtronic Bakken Research Center:
Coronary Artery Disease
Drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014